7. Ethics and institutional review

What is ethics review and how should it be negotiated? As part of the development of a research project, review by a properly constituted research ethics committee is now a standard expectation of most institutions. The purpose of such a review is, ostensibly, to provide an objective and independent assessment of the harms and benefits to those who participate, as subjects, in the proposed research. Ethics review by committee has thus become established as a uniform aperture through which to pass research of all different shapes and sizes. In this section you will find information about how the idea for ethics review came about, how review boards operate, including who sits on them and the paperwork they issue.

Where did ethics committees come from?

In a critical account of the ‘rise of ethical regulation’ in British social sciences, Dingwall (2016) traces a genealogy of research ethics. It begins with ‘the creation myth of research ethics’ (that is, the abuses to which the Nuremberg Code was a response), on through US National Institutes of Health (NIH) and the formation of expert committees to review human subject research in the 1950s (Stark 2012), and on to the widespread use of institutional review boards (IRBs). Much of the early activity of IRBs appears to have been driven by the NIH wishing to place an administrative tier between itself and the researchers participating in the studies it funded (hence the prominence of the word ‘institutional’ in the designation IRB). The intention was not so much human subject protection as the avoidance of litigation. In a kind of arcing across different national research environments, these committees also began to spring up in centres that were in receipt of NIH funding. For example, Hedgecoe (2009) shows how some NIH funded centres in the UK responded by creating their own ethics review processes.

In the 1970s, considerable impetus was given to the formal and widespread use of ethics review in the wake of the Tuskegee Syphilis experiment. Between 1932 and 1972 research conducted by the US Public Health Service observed the natural progression of untreated syphilis among poor Afro-American agricultural workers in Alabama. When it was brought to light that these men and women were still being studied long after the availability of penicillin as a safe and effective cure for the disease, a major scandal broke out. The upshot was the establishment of a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the eventual publication of the Belmont Report in 1979. The Belmont Report is a crucial point in the history of ethics review by committee, because it mandated the review of all federally funded research involving human subjects. The linkage between funding and ethics review is contained in regulation ’45 CFR 46’, known since 1991 as the ‘common rule’ (Lederman 2006:478, Brenneis 2005:240-241). Following the Belmont report, IRBs proliferated and became known by a variety of titles: independent ethics committees (IECs), ethics review boards (ERBs), or research ethics boards (REBs). They also spread in terms of their disciplinary jurisdictions. Throughout this document, the term that we use to describe these bodies as research ethics committees (RECs).

As the ethics review net widened in the US, concerns were expressed by anthropologists about the implication for their research. For example, an American Ethnologist forum on institutional review suggested serious tensions emerging as the practice of anthropology was brought more firmly within the reach of this legislation. Contributors expressed their dismay about ‘hypervigilance’ , ‘IRB mission-creep’ (Lederman 2006:482), loss of academic freedom (Shweder 2006:509) and a basic mismatch between the methodology of ethics review and the epistemology of the social sciences (Fassin 2006:524 also see Swartz 2007).

In the UK, a similar trajectory was unfolding. Justified by reference back to the potential for abuse of human subjects, a machinery for objective and anticipatory review of research proposals began with medical researchers and then proliferated across the other institutions overseeing research. With this proliferation came the need to standardise procedures and improve training for those charged with responsibility for reviewing. Much of the running in this regard has been made by medical and behavioural scientists for whom the issues of subject protection have been most pressing. However, templates from the biomedical sciences when used to assemble RECs in other disciplines have retained much of their original character. In short, many aspects of the form, function and rationale for RECs in the social sciences are modelled on those that were previously established for the medical sciences.

What is an ethics review committee?

An ethics review committee (REC) is essentially a body of people vested with authority to review, comment on and request clarification or modification to a piece of research prior to it commencing. A REC is, to use Stark’s characterisation, ‘a declarative body’, that is ‘a group of knowledge experts who are empowered by law to make decisions for citizens’ (Stark 2012, 5). Given an ethics committee’s role as a sentinel watching over the conduct of researchers who might, intentionally or unintentionally, cause harm, it is not surprising that undertaking research without formal approval can bring a number of serious consequences for a researcher, and particularly in the event of a dispute or incident in which a researcher’s practices are called into question. Proceeding without ethics review might invite professional censure from a department or university. It could result in the blocking or withdrawal of research funding. Gatekeepers, or perhaps even informants, might themselves ask for evidence of formal ethics review and see its absence as cause for suspicion. Finally, an increasing number of journals request evidence of ethics review as part of the submission process leading to publication. In short, ethical approval has come to act as a kite mark or official endorsement not only of the safety of a piece of research, but also regarding the very integrity and probity the researcher.

In order to be able to claim the authority to give such an endorsement, an ethics review committee must be made up of people competent to review applications and independent in their judgment. Procedures should be transparent and accountable. Decisions are expected to be made in a timely fashion (delay obtaining approval can play havoc with one’s carefully constructed Gantt chart!). Guidance on what makes a committee bona fide is usually contained in the standard operating procedures (SOPs) by which a REC is established and run.

Responsibility for obtaining appropriate review, in theory at least, lies with the researcher but there is considerable onus on the organisation under whose auspices it is carried out to provide the machinery for ethics review, as well as to see that it is used. In some research organisations (ROs), all review activity is carried out centrally whereas in others the work delegated to secondary RECs (for example, at faculty or department level). As we will see in the section on ‘Paperwork’, the different levels at which review might be carried out within an RO makes for considerable variation in the way that review impinges on the research process. In general terms, the more centralised the review process, the more it is likely to be a one-size-fits-all process, and the greater the tendency for disciplinary outliers, such as ethnography, to be recast in the process. Conversely, the closer the process to the disciplinary community, the greater the likelihood that review will not only be appropriate but also sympathetic to its methodological specificities.

Centralisation also opens up the possibility that a host of institutional concerns subsidiary to human subject protection per se might become part of the review agenda. These might include aspects of researcher insurance and liability, data protection, and most recently in the UK, anti-terrorism measures. In UK Universities the entanglement between research and counter-terrorism measures has been propelled by the Terrorism Act (2000) which makes it an offence for an individual to collect or make a record of information of a kind likely to be useful to a person committing or preparing an act of terrorism. Specifically, the Counter-Terrorism and Security Act (2015) requires Universities “to have due regard…to the need to prevent people from being drawn into terrorism.” For researchers working with communities or groups who may be perceived as part of a terrorism threat such legislation can prove very challenging. One solution that many institutions have adopted is to incorporate compliance with anti-terror legislation, known as the ‘Prevent Duty’, as part of the ethics review process (for example see, the University of Edinburgh’s notice on Counter-Terrorism and Security). Whilst this achieves the institutional objective of ensuring that data stored is generated by bona fide research, it has little to do with the ethics of subject protection per se. Universities are also seeking to offer protection to their researchers by establishing secure servers on which all sensitive (ie terror- or security- related) material are being stored – ie sensitive material should not be kept on personal computers. In the event of an enquiry or investigation the defence would be at the institutional level and not at the individual level. Even though the Prevent Duty is intended to apply to a very particular set of circumstances there is nonetheless anxiety among anthropologists working on sensitive topics or groups that the definitions and boundaries of the legislation are fluid and at the end of the day institutions would opt for legal compliance if faced with a challenge by a researcher.

Paperwork!

The most important interface that a researcher is likely to have with a REC is the paperwork that has to be submitted. At our colloquium in Durham, we set up an exercise which required small groups to review and critique the documentation that has to be filled out in order to gain ethical approval for research in four UK institutions chosen more or less at random. This exercise proved to be very revealing in terms of the way that these pro forma were inflected with the assumptions and values of the ROs that had created them. Moreover, the range of variation in purpose became very apparent when these were reviewed side by side.

Style and formality: the layout of the forms suggested different degrees of distance between the committee and the applicant. Some forms were highly bureaucratic in their style and content as evident from their extensive instructions, checklists made rather more intimidating by lots of underlining, block capitals and declarations of varying length that had to be signed by researchers. None of the documents reviewed came across as ones intended to communicate facilitation, and in two instances gave the definite sense that the encounter was with a no-nonsense bureaucracy of some considerable power. Non-UK European colleagues declared themselves ‘appalled’ at the tone taken towards applicants in some of the forms. The catch-all nature of the forms meant that some questions simply did not make sense in the context of ethnography (for example ‘will you provide a full debriefing at the end of the data collection phase?’). Nonetheless, the manner in which the forms are presented can give the impression that ‘n/a’ will be regarded as in some way suspect. The visibility of institutional logos and the requirement that signed copies are countersigned by representatives of various levels of authority (heads of department, principal investigators, faculty officers etc) gives the act of submitting the form an even greater sense of gravitas.

Triangulation: although a range of documents are used by an ethics committee to evaluate research, in each case it was clear that there was a good deal of cross-referencing that both the researcher and the RO were expected to be aware of and, literally, signed up to. These points of triangulation include: documents (usually accessed through weblinks) covering institutional governance and ethics statements, researcher integrity declarations, professional codes of practice, research council ethics statements/ requirements/ fieldwork safety guidelines, data protection legislation, ethics training, glossaries and flowcharts. The ease with which links can be inserted into a form means that the institution can shift a good deal of responsibility from itself onto the researcher who is then faced with a major exercise in researching secondary documents in order to be fully compliant. It is difficult not to come away from this abundance of points to be connected with the question: ‘have I missed anything?’

Scope: although the pro forma submitted to a REC are ostensibly about assessing potential harm to research participants, they are marked with a variety of other institutional concerns and consequently their scope is rather more extensive. The forms we reviewed now had sections covering data protection and security arrangements. Some also had sections on travel and risk (’have university of X’s risk assessment procedures been followed?) and insurance (’does university of X’s insurer need to be notified about your project before insurance cover can be provided?’).

Experimentality: to varying degrees the forms had an expectation that the approach being followed, consistent with a model of experimentality, was one in which the conditions of the research could be anticipated. Consequently, questions about the numbers of people to be included in the study, their characteristics (vulnerable, competent to consent, what they might find ‘sensitive’) and the circumstances in which the research encounter will take place all tended to assume that answers can be known in advance and, moreover, that these can be held constant during the actual research. These assumptions rather suggest that researcher and subjects are in a transactional relationship in which what is passing back and forth can easily be characterised as questions asked that result in ‘data’ coming back the other way. Whilst this may capture some of what happens during anthropological fieldwork it falls far short of the complexity that makes up the encounter.

Who sits on an ethics committee?

The membership of a REC is usually stipulated in terms of expert roles, gender composition and community representation. In evaluating the ethical consequences of a piece of research, disciplinary competence is clearly essential and, as such, the bulk of REC membership is drawn from the RO itself. However, an important feature of ethics committees is that they are generally required to have at least one external member. This is the ‘lay member’ or representative of the ‘citizens’ that Stark refers to above. This person connects an ethics committee, even if only symbolically, to the wider society. She/he is there to see that research is conducted in keeping with the values and expectations of ‘ordinary people’. One way of thinking of the role of the external member is that they are there to represent and give voice to the research subjects identified in a proposal and to act as a corrective should the interests of research at any point appear to override their interests.

Given the different positions that a REC might take within an organisation, the specificities of its composition and the range of functions it covers, it is not unreasonable for a researcher to ask ‘what is my relationship with it?’ Unsurprisingly, there is not a single answer. At our colloquium, participants gave varying accounts. At one end of the spectrum, some participants reported impersonal and officious treatment by RECs whose members lacked understanding of the approaches they were reviewing. Words used to characterise this kind REC intervention included: ‘bureaucratic’, ‘overly codified’, ‘naive’, ‘adversarial’ and ‘fetishised’. It was suggested that in these instances, RECs were more likely to be interested in bureaucratic efficiency, legal defensiveness and reputation management. However, as Robert Dingwall put it, the idea that ethical regulations are an untrammelled good needs to be questioned: “is it proportionate to the ignorance it creates?” At the other end of the spectrum, some very positive experiences with RECs were reported by ethnographers. In these instances, RECs were described as enabling and facilitative with members trying to understand and engage directly with the content of the proposal in an open and iterative way. This kind of closeness between researchers and REC members, however, led one participant to express concern that it might compromise its independence. In between these positions were views which saw ethics review as neither help nor hindrance, but a necessary part of the bureaucracy of professionalism.

When approaching ethics review in practice, a first step is to gain some understanding of the procedures that are in place in your own institution. Familiarisation might involve looking at what the REC says about itself (composition, objectives, SOPs etc) and making contact with members to find out more about how they understand what they think they are doing and how it might (or might not) relate to what you hope to do.

Bibliography

Robert Dingwall, (2012), How did we ever get into this Mess? The Rise of Ethical Regulation in the Social Sciences, in Kevin Love (ed.) Ethics in Social Research (Studies in Qualitative Methodology, Volume 12) Emerald Group Publishing Limited, pp.3 - 26

Fassin,D (2006).. The end of ethnography as collateral damage of ethical regulation? American Ethnologist, 33, pp.522-4

Hedgecoe, A., (2009) “A form of practical machinery”: the origins of research ethics committees in the UK, 1967–1972. Medical history, 53(3), pp.331-350.

Lederman, R. (2006). “Introduction: Anxious borders between work and life in a time of bureaucratic ethics regulation”. American Ethnologist, 33(4), 477-481.

Shweder, R.A., (2006) Protecting human subjects and preserving academic freedom: Prospects at the University of Chicago. American Ethnologist, 33(4), pp.507-518.

Stark LJM (2012) Behind closed doors: IRBs and the making of ethical research. Chicago & London: University of Chicago Press.